Detailed Guidance on ICSRs in the Context of COVID-19

On 13 April 2022 the EMA published updated guidance revision 3, clarifying the validity and coding of ICSRs linked to COVID-19.

This detailed guidance document provides recommendations relevant to the processing and submission of Individual Case Safety Reports (ICSRs) associated with medicinal products used for the treatment or prevention of COVID-19 infection, taking into account:

  • the Notice to stakeholders published by the European Commission;
  • the guidance regarding COVID-19 related terms published by the MedDRA MSSO; and
  • the introduction of COVID-19 related terms since the updated MedDRA version 23.0.
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